Note: This document contains side effect information about alglucosidase alfa. Some dosage forms listed on this page may not apply to the brand name Lumizyme.

Summary

Common side effects of Lumizyme include: bradycardia, cough, fever, infusion related reaction, oxygen desaturation, skin rash, tachycardia, tachypnea, urticaria, vomiting, and flushing. Continue reading for a comprehensive list of adverse effects.

Applies to alglucosidase alfa: intravenous powder for solution.

Serious side effects of Lumizyme

Along with its needed effects, alglucosidase alfa (the active ingredient contained in Lumizyme) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking alglucosidase alfa:

More common

• Blue lips, fingernails, or skin
• body aches or pain
• chest discomfort or pain
• chills
• cough
• difficult or labored breathing
• difficulty with swallowing
• dizziness
• dry, red, hot, or irritated skin
• ear congestion
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever
• headache
• hives, itching, or skin rash
• increased sweating
• irregular, fast, slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• loss of voice
• nasal congestion
• pain
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid shallow breathing
• redness of the face, neck, arms, and occasionally, upper chest
• redness or pain at the catheter site
• runny nose
• shakiness in the legs, arms, hands, or feet
• slow or irregular heartbeat
• sneezing
• sore throat
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in the chest
• trembling or shaking of the hands or feet
• troubled breathing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Blood in the urine
• convulsions
• decreased urine
• dry mouth
• increased thirst
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• pain in the groin or genitals
• sharp back pain just below the ribs

Incidence not known

• Blue-green to black skin discoloration
• blurred vision
• confusion
• dilated neck veins
• extreme fatigue
• heart stops
• inability to speak
• no breathing
• no pulse or blood pressure
• pain, redness, swelling, or sloughing of the skin at the place of injection
• seizures
• severe or sudden headache
• severe pain in the chest
• slurred speech
• sudden and severe weakness in the arm or leg on one side of the body
• sudden onset of severe breathing difficulty
• swelling of the face, fingers, feet, or lower legs
• temporary blindness
• unconscious
• weight gain

Other side effects of Lumizyme

Some side effects of alglucosidase alfa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain
• acid or sour stomach
• belching
• body aches or pain
• change in hearing
• congestion
• constipation
• dryness or soreness of the throat
• ear discomfort or pain
• ear drainage
• earache
• feeling of constant movement of self or surroundings
• general feeling of discomfort or illness
• heartburn
• hoarseness
• indigestion
• muscle or bone pain, stiffness, or tightness
• muscle twitching
• redness of the skin
• redness or swelling in the ear
• sensation of spinning
• sore mouth or tongue
• stomach discomfort, upset, or pain
• tender, swollen glands in the neck
• upper abdominal or stomach pain
• voice changes
• welts
• white patches in the mouth or on the tongue

Less common

• Bloody nose
• sleepiness or unusual drowsiness

Incidence not known

• Burning, dry, or itching eyes
• discharge, excessive tearing
• muscle spasm
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

For Healthcare Professionals

Applies to alglucosidase alfa: intravenous powder for injection.

General

The most common side effects were hypersensitivity reactions, fever, diarrhea, rash, vomiting, cough, pneumonia, otitis media, upper respiratory tract infection, gastroenteritis, and decreased oxygen saturation. The most serious side effects were anaphylactic reactions, acute cardiorespiratory failure, and cardiac arrest. The most common serious side effects were pneumonia, respiratory failure, respiratory distress, catheter-related infection, respiratory syncytial virus infection, gastroenteritis, and fever.^[Ref]

Hypersensitivity

The most common side effects that required intervention in clinical trials in infantile-onset and juvenile-onset Pompe disease were hypersensitivity reactions (51%) and included rash, pyrexia, urticaria, flushing, decreased oxygen saturation, cough, tachypnea, tachycardia, hypertension/increased blood pressure, pallor, rigors, vomiting, cyanosis, agitation, and tremor. These side effects occurred more often with higher infusion rates. Hypersensitivity reactions were reported in some patients who were pretreated with antihistamines, antipyretics, and/or corticosteroids.

Delayed-onset hypersensitivity reactions (defined as side effects occurring 2 to 48 hours after infusion) included hyperhidrosis, fatigue, myalgia, and nausea.

Hypersensitivity reactions in infantile-onset Pompe disease patients included livedo reticularis, irritability, retching, increased lacrimation, ventricular extrasystoles, nodal rhythm, rales, respiratory tract irritation, and cold sweat.

Anaphylaxis and hypersensitivity reactions (included anaphylactic shock, respiratory failure, respiratory arrest, cardiac arrest, hypoxia, dyspnea, wheezing, convulsions, peripheral coldness, restlessness, nervousness, back pain, stridor, pharyngeal edema, abdominal pain, apnea, muscle spasm, conjunctivitis) have been reported during postmarketing experience.^[Ref]

Very common (10% or more): Hypersensitivity reactions (included anaphylaxis, headache, nausea, urticaria, dizziness, chest discomfort/pain, vomiting, hyperhidrosis, flushing/feeling hot, paresthesia, pyrexia, local swelling, diarrhea, pruritus, rash, throat tightness, fatigue, myalgia, cough, decreased oxygen saturation, tachycardia, tachypnea, muscle twitching, agitation, cyanosis, erythema, hypertension/increased blood pressure, pallor, rigors, tremor, livedo reticularis, irritability, retching, increased lacrimation, ventricular extrasystoles, nodal rhythm, rales, respiratory tract irritation, cold sweat, anaphylactic shock, respiratory failure, respiratory arrest, cardiac arrest, respiratory distress, hypoxia, dyspnea, bradycardia, bronchospasm, hypotension, angioedema [including tongue or lip swelling, periorbital edema, face edema], wheezing, convulsions, peripheral coldness, restlessness, nervousness, back pain, stridor, pharyngeal edema, abdominal pain, apnea, muscle spasm, conjunctivitis)

Common (1% to 10%): Anaphylaxis (presented as angioedema, throat tightness, chest pain/discomfort)

Postmarketing reports: Systemic and cutaneous immune-mediated reactions (including proteinuria and nephrotic syndrome secondary to membranous glomerulonephritis, ulcerative and necrotizing skin lesions)^[Ref]

Cardiovascular

Supraventricular tachycardia was reported in a patient with history of Wolff-Parkinson-White syndrome.

Acute cardiorespiratory failure (possibly associated with fluid overload) was reported in infantile-onset Pompe disease patients with preexisting hypertrophic cardiomyopathy.^[Ref]

Very common (10% or more): Tachycardia (up to 23%), flushing (up to 21%), bradycardia (up to 21%)

Common (1% to 10%): Hypertension, increased blood pressure, pallor, cyanosis

Frequency not reported: Supraventricular tachycardia, cardiac arrest, hypotension, vasoconstriction, increased heart rate, decreased blood pressure, decreased heart rate

Postmarketing reports: Acute cardiorespiratory failure^[Ref]

Other

Very common (10% or more): Pyrexia (up to 92%), infusion reactions, otitis media (up to 44%), ear infection (up to 33%), catheter-related infection (up to 28%), postprocedural pain (up to 26%)

Common (1% to 10%): Malaise, rigors, chest discomfort, flushing/feeling hot, peripheral edema, chills, fatigue, increased body temperature

Frequency not reported: Chest pain, face edema, peripheral coldness, enzyme activity inhibited, enzyme uptake inhibited, lethargy, hypothermia

Postmarketing reports: Recurrent reactions (consisting of influenza-like illness or combination of events [e.g., pyrexia, chills, myalgia, arthralgia, pain, fatigue]) after infusion^[Ref]

The most common side effects that required intervention in clinical trials in infantile-onset Pompe disease were infusion reactions (defined as side effects occurring during or within 2 hours after infusion; 51%) and included rash, fever, urticaria, flushing, decreased oxygen saturation, cough, tachypnea, tachycardia, hypertension, increased blood pressure, irritability, pallor, pruritus, retching, tremor, hypotension, rigors, vomiting, cyanosis, agitation, bronchospasm, erythema, face edema, feeling hot, headache, hyperhidrosis, increased lacrimation, livedo reticularis, nausea, periorbital edema, restlessness, wheezing, cardiac arrest, bradycardia, angioedema, pharyngeal edema, peripheral edema, chest pain, chest discomfort, dyspnea, muscle spasm, fatigue, respiratory distress, throat tightness, and conjunctivitis. Infusion reactions were reported more often in antibody-positive patients, especially those with high antibody titers.

Recurrent reactions consisting of influenza-like illness or a combination of events (e.g., pyrexia, chills, myalgia, arthralgia, pain, fatigue) after infusion generally lasted for 1 to 3 days.

Severe and serious infusion reactions (including cardiac arrest, respiratory arrest, apnea, stridor, pharyngeal edema, peripheral edema, chest pain, chest discomfort, muscle spasm, fatigue, conjunctivitis) have been reported during postmarketing experience.^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 62%), vomiting (up to 49%), gastroenteritis (up to 41%), oral candidiasis (up to 31%), gastroesophageal reflux disease (up to 26%), constipation (up to 23%), upper abdominal pain (up to 15%)

Common (1% to 10%): Retching, nausea

Frequency not reported: Abdominal pain^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 54%), diaper dermatitis (up to 36%), urticaria (up to 21%)

Common (1% to 10%): Erythema, pruritus, hyperhidrosis, papular rash, macular rash, maculopapular rash

Frequency not reported: Erythematous rash, livedo reticularis, palmar erythema

Postmarketing reports: Ulcerative and necrotizing skin lesions^[Ref]

Respiratory

Very common (10% or more): Cough (up to 46%), pneumonia (up to 46%), upper respiratory infection (up to 44%), pharyngitis (up to 36%), respiratory distress (up to 33%), respiratory failure (up to 31%), rhinorrhea (up to 28%), tachypnea (up to 23%), bronchiolitis (up to 23%), nasopharyngitis (up to 23%)

Common (1% to 10%): Rhinitis, throat tightness

Frequency not reported: Respiratory arrest, apnea, bronchospasm, wheezing, pharyngeal edema, dyspnea, stridor, respiratory syncytial virus infection, increased respiratory rate, rales^[Ref]

Metabolic

Very common (10% or more): Decreased oxygen saturation (up to 41%)

Frequency not reported: Increased blood calcium^[Ref]

Immunologic

Very common (10% or more): IgG antibodies to alglucosidase alfa (the active ingredient contained in Lumizyme) (up to 100%)

Frequency not reported: Development of alglucosidase alfa-specific IgE antibodies, development of neutralizing antibodies^[Ref]

Hematologic

Very common (10% or more): Anemia (up to 31%)

Frequency not reported: Decreased hemoglobin, decreased platelet count^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle twitching, myalgia, muscle spasms, increased blood creatine phosphokinase MB

Frequency not reported: Arthralgia, increased blood creatine phosphokinase^[Ref]

Nervous system

Common (1% to 10%): Headache, tremor, paresthesia, dizziness^[Ref]

Psychiatric

Common (1% to 10%): Agitation, insomnia, irritability

Postmarketing reports: Restlessness^[Ref]

Local

Common (1% to 10%): Local swelling

Frequency not reported: Infusion site pain, infusion site reaction^[Ref]

Renal

Frequency not reported: Increased blood urea

Postmarketing reports: Nephrotic syndrome (secondary to membranous glomerulonephritis)^[Ref]

Genitourinary

Postmarketing reports: Proteinuria

Endocrine

Postmarketing reports: Hyperparathyroidism^[Ref]

Hepatic

Frequency not reported: Increased ALT, increased AST

Ocular

Frequency not reported: Conjunctivitis, periorbital edema, increased lacrimation